UMIN-CTR Clinical Trial

Basic information
Public title	Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Acronym	Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Scientific Title	Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Scientific Title:Acronym	Clinical outcome of risedronate therapy for patients with Paget's disease of bone
Region	Japan

Condition
Condition	Paget's disease of bone
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of high dose resedronate for patients with Paget's disease of bone
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ALP value
Key secondary outcomes	pain

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	risedronate 17.5mg
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	ALP value over normal range
Key exclusion criteria	not tolerated for risedronate
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Nishida
Organization	Nagoya University Hospital
Division name	Orthopaedic Surgery
Zip code	4668550
Address	65-Tsurumai, Showa, Nagoya
TEL	052-741-2111
Email	ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Nishida Middle name Last name Yoshihiro
Organization	Nagoya University Hospital
Division name	Orthopaedic Surgery
Zip code	466-8550
Address	65-Tsurumai, Showa, Nagoya
TEL	052-741-2111
Homepage URL
Email	ynishida@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	JAPA:Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya University
Address	Orthopaedic surgery, 65-Tsurumai
Tel	0527412111
Email	ethics@med.nagoya-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Watching the progress of the case
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 04 Month 01 Day
Date of IRB	2009 Year 04 Month 25 Day
Anticipated trial start date	2009 Year 05 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Other
Other related information	Analysis completed

Management information
Registered date	2015 Year 10 Month 14 Day
Last modified on	2021 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022363